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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03354468
Other study ID # 2015/2469
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2011
Est. completion date October 31, 2014

Study information

Verified date January 2019
Source Helse Møre og Romsdal HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The incidence of fractures in Norway is among the highest in the world, and falls are the sixth major contributor to years lived with disability. In elderly, a large part of 900 deaths from unintentional injuries per 100000 inhabitants per year, are due to falls and fractures. Fractures, especially hip fractures among the elderly, often result in pain, ailments, and reduced quality of life. In Norway, 11 % of all reports from the specialized health services were incidents related to falls. Worldwide, falls are among the most commonly reported adverse events in hospitals with prevalence rates in the order of 10 per 1000 patient days or 5-15 % of the patients, and are associated with both minor and major injuries. The results of preventive measures are conflicting.

In January 2011, the Norwegian health minister launched a national patient safety campaign called "In Safe hands". The campaign had three aims: 1) Reduce patient related adverse events, 2) Build sustainable systems and structures for patient safety, and 3) Improve the patient safety culture. Hospitals and primary care units were invited to participate in 16 specific and measurable areas for improvement. One out of four orthopedic departments at Møre og Romsdal Hospital Trust, Norway participated actively in a fall prevention program.

This study compares the changes in fall rates, the employees' perceived patient safety culture and the patient experienced safety before and after implementation of the fall prevention program at the orthopedic department in one hospital in the Møre & Romsdal Hospital Trust, and at the same time points i another hospital in the same Trust but not having implemented the program.


Description:

The interventions are multifaceted and include short and long-term activities to prevent falls. Fall screening, performed with the Norwegian version of the risk assessment tool for falls in elderly "STRATIFY (score 0 - 5), is the main tool. In patients with a score of 2 or more, a comprehensive individual plan for fall prevention has been worked out for each patient with risk of fall, documented in the medical records, and communicated to the staff responsible for the patient. The plan includes practical initiatives like adjusting the beds, proper illumination, instructions not to leave the bed unaided, and appropriate shoes. There are also long-term measures like the treatment of underlying diseases, changes in medication associated with risk of fall, physical training, and healthier dietary habits. During the intervention, the process is measured and reported to the national campaign. The national intervention was designed for use in hospitals, care facilities and patients living at home. Most of the proposed activities aim at preventing falls in a long time perspective.


Recruitment information / eligibility

Status Completed
Enrollment 3143
Est. completion date October 31, 2014
Est. primary completion date October 31, 2014
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- admitted to the orthopedic department at Kristiansund Hospital or Ă…lesund Hospital

- admitted during one the two registration periods: from November 1, 2011 to October 31, 2012; or from November 1, 2013 to October 31, 2014

- a stay in the hospital of at least 24 hours' duration

Exclusion Criteria:

- n.a.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
fall prevention program
fall prevention program in orthopedic department, consisting of 1) Seven examples of risk factors which might cause falls (diseases and medications, movement, cognitive behavior, vision, continence, nutrition, and the room and surroundings), 2) Methods to detect the risk factors, and 3) Measures to avoid falls or protect the patient in case of a fall.

Locations

Country Name City State
Norway Dept of Orthopedics Ålesund
Norway Dept of Orthopedics Kristiansund

Sponsors (3)

Lead Sponsor Collaborator
Helse Møre og Romsdal HF Norwegian University of Science and Technology, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Røyset B, Talseth-Palmer BA, Lydersen S, Farup PG. Effects of a fall prevention program in elderly: a pragmatic observational study in two orthopedic departments. Clin Interv Aging. 2019 Jan 15;14:145-154. doi: 10.2147/CIA.S191832. eCollection 2019. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of fallers during the registration period 1 year registration period
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